Friday, February 11, 2011

Aminovel 600

AMINOVEL® 600
Amino Acids, Carbohydrates, Electrolytes, Vitamins
For Intravenous Administration

AMINOVEL® 600 is a well-balanced mixture of L-Amino acids optimally proportioned for maximum protein synthesis. Sorbitol, vitamins and electrolytes supplement or nutritional needs for the body.

COMPOSITION (Each 500 mL contains):
Amino acids (L-form)25.0gSodium35mEq/L
D-Sorbitol50.0gPotassium25mEq/L
Ascorbic acid200.0mgMagnesium5mEq/L
Inositol250.0mgAcetate35mEq/L
Nicotinamide30.0mgMalate22mEq/L
Pyridoxine HCl20.0mgChloride38mEq/L
Riboflavin Sodium Phosphate1.25mg
Water for Injectionad 500 mLOsmolarityApprox.1160 mOsm/L

CONTENTS OF 25.0 g AMINO ACIDS:
L-Isoleucine1.60gL-Valine1.60g
L-Leucine1.20gL-Arginine (calculated as base)3.10g
L-Lysine (calculated as base)1.00gL-Histidine (calculated as base)0.50g
L-Methionine1.50gL-Alanine3.00g
L-Phenylalanine2.00gGlycine7.00g
L-Threonine1.00gL-Proline1.00g
L-Tryptophan0.50g

AMINOVEL® 600 is a sterile aqueous solution supplying approx. 600 calories per liter. Each lot is examined by exothermic substance test, sterility test and toxicity test and is manufactured under the severe standard.

INDICATIONS
AMINOVEL® 600 is recommended for parenteral nutrition supply in the following conditions:
  1. As supplement nutrition in the case of the impairment of the gastrointestinal tract as in clinical situation of short bowel syndrome, anorexia and severe gastrointestinal disorder.
  2. Prolonged gastrointestinal rest is necessary as in case of enterocutaneous fistulae and involving the gastrointestinal tract.
  3. In increased metabolic need as in the cases of severe burns,  trauma and after surgery.
  4. In other critical cases, which require exogenous nutrition such as tumor, severe infections, severe stress and protein deficiency.
CONTRA INDICATION
Patients with hypersensitivity to one of the components of solution.

DOSAGE AND ADMINISTRATION
  1. For internal disorder or presurgical protein deficiency: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) simultaneously or followed by a 10% sugar solution 500 mL over 2 hours (60-80 drops per minute). These infusions are repeated at 12 hours intervals for 5-7 days.The intervals may be prolonged to 24 hours according to patients condition and response.
  2. For post surgical impairment of protein synthesis: The usual adult dosage is 500 mL of AMINOVEL® 600 by intravenous drip infusion over 4-6 hours (20-30 drops per minute) following drip infusion of Darrow's solution 1000 mL over 4 hours (60-100 drops per minute) and followed by drip infusion of a 10% sugar solution 500 mL over 2 hours (60-100 drops per minute). These infusions are started on the third post surgical day and repeated at 24 hours intervals for 5-7 days.
ACTIONS AND CHARACTERISTICS
AMINOVEL® 600 supplies the following essential components for parenteral nutrition:
  1. L-forms of amino acids which can be only utilized in the body for the synthesis of its various protein constituents; It is known that the body does not normally preserve nitrogen balance with D-isomers of amino acids.
    • The eight essential amino acids: L-Isoleucine, L-Leucine, L-Lysine, L-Methionine, L-Phenylalanine, L-Threonine, L-Tryptophan and L-Valine are indispensable for protein synthesis.
    • The semi essential amino acids:
      • L-Histidine utilizes optimally amino acid mixtures and is essential for infants and in uraemia;
      • L-Arginine utilizes optimally amino acid mixtures and is essential for detoxication.
    • L-Alanine and L-Proline are necessary for optimal utilization of amino acid mixtures.
    • Glycine is a source for nonspecific nitrogen.
  2. Sorbitol to supply sufficient non nitrogen calories to meet metabolic energy requirements.
  3. Vitamins to prevent deficiencies and to promote the bio synthesis of protein.
  4. Minerals to maintain electrolyte balance and to promote synthesis of protein.
  5. Water to meet the body's requirements.
AMINOVEL® 600 provides all these substances in the optimal and exactly balanced proportions necessary to ensure maximum protein synthesis without depletion of the body's own reserves.

CAUTION
  1. Careful checking should be done for urine volume not to be less than 60-70 mL per hour and reexamination of dosage schedule is necessary when the volume falls below the level.
  2. Use immediately after breaking the seal and do not use the remaining solution.
  3. Take special care of handling the instruments for injection as these preparation are liable to propagate germs.
  4. Open the outer wrap just before use.
  5. Do not use if bag is leaking, solution cloudy or contains foreign matters. I
  6. Maximum infusion rate is 3 cc per minute.
STORAGE
Store below 30°C, protect from light

PACKAGE
Box, 1 soft bag of 500 mL
REG NO.: DKL9218702749A1

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Manufactured by:
PT. Otsuka Indonesia
Jl. Sumber Waras No. 25
Lawang, Malang 65216, Indonesia

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